PLECANATIDE: A COMPREHENSIVE REVIEW OF ITS SYNTHESIS, ANALYTICAL METHOD AND VALIDATION OVERVIEW

Dharani C.* and Vetrichelvan T.

ABSTRACT

Plecanatide, a guanylate cyclase-C receptor agonist structurally related to Uroguanylin, has emerged as a therapeutic agent for chronic idiopathic constipation and irritable bowel syndrome with constipation (IBS-C). This review provides a comprehensive analysis of its Pharmaceutical profile, beginning with synthetic strategies and key patents shaping its development. Molecular dynamics simulations offer insights into conformational stability and receptor binding characteristics. The physical and chemical properties of Plecanatide are discussed in the context of its formulation, stability, and storage. Its mechanism of action is explored through its activation of cyclic GMP pathways leading to improved intestinal fluid balance. And also examine Pharmacokinetic and Pharmacodynamic data that underpin its clinical application. Regulatory status, including US-FDA approval and related guidelines is summarized. Instrumental analytical techniques that were created and utilized to detect the presence of a drug alone in bulk drugs formulations have been studied, and the literature from various journals relating to Pharmaceutical analysis has been thoroughly reviewed, with emphasis on method development and validation parameters in accordance with ICH guidelines. The most recent analytical techniques are covered in this review, including chromatographic techniques like RP-HPLC. This review aims to serve as a comprehensive reference for researchers, formulators and analysts involved in gastrointestinal drug development and regulatory submission.

Keywords: Plecanatide, guanylate cyclase-C, peptide drug, analytical method validation, Pharmacokinetics, Pharmaceutical analysis, synthesis, regulatory affairs.